Archer is a young, dynamic and growing Contract Research Organization (CRO) based in Bioville, Diepenbeek, Belgium. We are specialized in providing full support for clinical studies with medical devices in Europe.
As a CPM/CRP you manage and conduct clinical studies by respecting all regulatory requirements and Good Clinical Practice (GCP). You are the primary contact for sponsor and responsible to ensure the quality and integrity of the clinical data, together with Clinical Research Associates (CRA). You will manage multiple projects within different therapeutic areas, and you are able to work both independently and in a team environment.
You will have the opportunity to be involved in this constantly growing and inspiring international environment.
What is your role?
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Lead the planning, execution, monitoring and closeout of clinical studies in accordance with the Clinical Investigational Plan, regulatory requirements and sponsor expectations.
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Serve as the primary point of contact for sponsors, ensuring effective communication and high levels of client satisfaction.
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Develop and manage project timelines, budgets, resource plans and study milestones.
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Coordinate cross-functional teams, including Clinical Research Associates (CRAs), Clinical Trial Assistants (CTA), data management, biostatistics, regulatory affairs and medical writing.
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Oversee study start-up activities, including site selection, site initiation, ethics committee and regulatory authority submissions and project team training.
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Support and oversee the set-up and validation of the electronic data capture (EDC) system and/or case report form (CRF) design.
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Coordinate study conduct activities, including safety reporting, data management, risk-based and central monitoring and timely client reporting.
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Oversee the study close-out activities, including database lock, biostatistics, medical writing.
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Keep track of the study budget from study start to close-out and report to client and senior management.
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Monitor project progress and key performance indicators, identifying and mitigating risks to study timelines, quality and budget.
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Ensure compliance with GCP, ISO 14155, MDR 2017/745, applicable local regulatory requirements and company or client standard operating procedures (SOPs).
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Write, review and approve study-related documentation, including clinical study functional plans, status reports and trial master file (TMF) documentation.
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Manage vendor and subcontractor activities to ensure timely and high-quality deliverables.
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Facilitate project meetings, prepare status updates and provide regular reports to sponsors and senior management.
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Support inspection and audit readiness and participate in sponsor, regulatory authority or internal audits as required.
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Contribute to process improvement initiatives and the development of project management best practices within the organization.
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Mentor and support junior clinical operations staff and contribute to team development.
Who are we looking for?
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Education: Master's or Ph.D. degree in one of the Life Sciences or Bachelors degree in Life Sciences with min. of 5 years relevant experience in clinical studies.
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Awareness of applicable clinical research regulatory requirements; i.e. GCP guidelines, General Data Protection Regulation (GDPR).
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Awareness of the applicable standards and national regulations. E.g. ISO9001, ISO14155 and EU Regulations for medical devices (MDR 2017/745).
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Computer skills, including working knowledge of Microsoft Word, Excel, PowerPoint, Electronic Data Capture (EDC) and eTMF systems.
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Personality: pro-active, independent, team player, well-structured, flexible, precise, responsible, result driven.
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Excellent written and verbal communication skills including good command of English, knowledge of German and/or French.
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Ability to build and maintain effective relationships with colleagues, site staff, representatives, stakeholders and sponsors.
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Effective time management and organizational skills, ability to manage multiple priorities across various clinical studies within various disciplines.
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Strong negotiation, decision-making and conflict-resolution skills.
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Ability to easily adapt to new ways of working, traveling or new projects.
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Certifications such as but not limited to: GDPR, ICH-GCP, ISO14155.
Interested to join the Archer Research team?
Do not hesitate to send your CV to info@archerresearch.eu.